It’s important to keep up with compliance mandates because the US Food and Drug Administration (FDA) keeps a close watch on the medical device industry. If there is an accident involving your devices, it could damage the lives of your patients and the reputation of your company. This article focuses on the most significant FDA quality regulatory programs to be aware of, and tips on how to avoid fines and court action for non-compliance. Read the full article here. For more information about keeping up with regulations, visit The Copley Consulting Group and Infor CloudSuite Industrial for Medical Devices.
Read More →SMTC Presentation: Driving Product Optimization Through Early Stage Supplier Engagement
Exploring Design for Excellence (DFX) Brian Morrison, from SMTC, took his wealth of knowledge and understanding as the Director of Value Engineering & Technology and presented crucial industry information at the American Medical Device Summit 2016. Take a look at Morrison’s insightful presentation from the Summit that explores Design for Excellence (DFX) Product Optimization, focusing on these core concepts: What is DFX? DFX Benefits Value Equation Product Design Review Ability to Impact Product Value Early Supplier Involvement (ESI) Impact of Design Decisions Applying DFX to Product Development To view the full presentation, click here. About SMTC SMTC is a mid-size provider of end-to-end electronics manufacturing services (EMS) including PCBA production, systems integration and comprehensive testing services, enclosure fabrication, as well as product design, sustaining engineering, and supply chain management services.
Read More →Maetrics: The ROI of Good Quality & Compliance
On October 5th, 2016 at the American Medical Device Summit in Chicago, Generis welcomed Maetrics to the speaker panel on Day One. Ed Roach, the Managing Director of Maetrics, focused his presentation on four main objectives being: Ideas on how to quantify the costs of quality for investment justification Understanding indirect or potential costs of quality and compliance including Examining FDA’s recent and future approach to Medical Devices The Potential Impacts of FDA’s approach to Medical Devices Understand the Benefits of a Proactive Quality System Benchmarking – Good Investments in Quality and Compliance To view the full presentation online, click here. Panel Speaker: Ed Roach, Managing Director of Maetrics Ed Roach brings nearly 20 years of experience in the life sciences industry to the panel while adding his wealth of knowledge on Quality Systems and Quality Assurance, Validation, Corrective and Preventive Actions (CAPS), Root Cause Investigation, Change Management, and 483/Warning Letter Remediation to the American Medical Device Summit. Generis is thrilled that Maetrics will be returning to Chicago for the American Medical Device Summit on October 4th and 5th in 2017. For more information on Generis or our American Medical Device Summit taking place in 2017, please, don’t hesitate to contact us today.
Read More →eBook: Realistic Simulation for Medical Device Developers
Medical device developers use realistic simulation solutions from SIMULIA to accelerate the overall product innovation process, reducing development costs, and improving patient safety and product quality. In addition, SIMULIA provides medical device companies with the ability to more efficiently evaluate design alternatives, accelerate long-term stress life testing to predict product reliability, collaborate on projects and leverage computing resources for more efficient design analysis. Check out the eBook below!
Read More →Video: Plasma Surface Treatment for Better and Lower Cost Cleaning & Bonding
Active microfluidic devices, sensors and implantable devices often require a specific binding property or binding capacity in order to change reactions with an environment or biological fluid The most common systems utilize specific functional groups such as amine, hydroxyl, or carboxyl for conjugation to protein, molecule, integrin, or adhesive component. Gas plasma begins by removing organic surface contaminants by reducing them to volatile compounds. The nascent surface is subsequently reacted to process specific plasma chemistry. Plasmatreat’s advanced plasma chambers, low pressure/batch or atmospheric pressure/inline are versatile tools that are capable of designing controlled interfaces on a variety of materials. This includes streamlining approaches where conventional multi-step wet chemistries are employed. Plasma gives the design engineer the freedom to separate mechanical, optical, and fabrication techniques from the surface requirements. Freedom of choice usually results in significant cost savings. With plasma surface treatment, the choices and capabilities are expansive. Plasma surface treatment is not one process, but an entire chemistry toolbox. Check out the Video below!
Read More →eBook: Design Thinking with Terumo BCT
Generis Group is honored to have Palani Palaniappan, EVP, Innovation and Development at Terumo BCT join the speaker faculty at the upcoming American Medical Device Summit 2016. With the summit right around the corner, we took the opportunity to sit down with Dr. Palaniappan to gather his insights and discuss the importance of ‘Design Thinking’ in the journey from concept to commercialization. Check out the eBook!
Read More →Whitepaper: Why Production Forecast Affects Sterilization Method
A validated sterilization cycle is a requirement for many medical devices, and the appropriate sterilization method will depend on two main factors. The Phase2Medical Whitepaper below discusses these factors and demonstrates the effect that production forecasts have on the up-front and long-term costs for two of the most common sterilization methods. Check out the Whitepaper below! Don’t forget to join Phase2Medical at the American Medical Device Summit 2016 taking place in Chicago next week!
Read More →eBook: Product Content Management in a Regulated Environment
In today’s environment of strict regulation and reduction in spending for healthcare, life sciences companies are under pressure to reduce operational costs, increase efficiency and provide greater value to the system—and sales enablement is a crucial component to achieving all of the above. In the eBook below, Seismic addresses some of the challenges that life sciences companies face and provides some solutions to these challenges. Check out the eBook below!
Read More →What Happens When Life Sciences Messaging Doesn’t Meet FDA Regulations
Medical device organizations face a number of regulatory and compliance challenges ranging from design and development to commercialization. In preparation for the American Medical Device Summit 2016 we wanted to share the post below to introduce some of the challenges that can arise when life sciences messaging doesn’t meet FDA standards. The Seismic blog post below discusses some common missteps life sciences marketers make when it comes to FDA compliant messaging, and the consequences to distributing non-compliant medical product promotional content. It also offers some simple solutions for avoiding those missteps. Check out the post!
Read More →eBook: How Quality is Your System?
With the American Medical Device Summit 2016 right around the corner we wanted to take some time to sit down with Clarkston Consulting to gather their insights on quality system management. Clarkston Consulting are specialists in management, operations, and implementation consulting services for life sciences and consumer products companies. To help guide medical device developers on their quality journey we asked Clarkston to adress: What to Consider in your Quality System Lifecycle Quality Systems Planning and Priorities What Are the Challenges and How Can You Overcome Them? The Benefits of the Lifecycle Approach Quality Acceleration and Overwatch Check out the eBook below!
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